{"preliminary_commentary":{"by_channel":{"x_thread":25,"youtube":16,"podcast":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT05767359\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["ciltacabtagene autoleucel"]],"indication":"high-risk smoldering multiple myeloma","name":"CAR-PRISM","nct_id":"NCT05767359","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=car-prism-nct05767359. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants will be enrolled into each of the 2 safety run-in phases in a standard 3 + 3 design.\n\n\\- Participants will undergo study procedures as outlined:\n\n* Apheresis for collection of peripheral blood mononuclear cells (PBMC) will occur on-site\n* Stem cell collection on-site post-apheresis per standard care.\n* Administration of Cyclophosphamide and fludarabine in pre-determined doses 1 x daily for 3 consecutive days.\n* Hospitalization to receive Cilta-cel in per-determined dose per protocol 1 x daily for 3 consecutive days and will remain in the hospital for 2 weeks post cilta-cell infusion.\n* Follow-up for 3 years post-treatment and up to 15 years.","label":"Safety Run-In","type":"EXPERIMENTAL"},{"description":"Expansion cohort of 14 participants will be enrolled after safety run-in phases, and participants will undergo study procedures as outlined:\n\n* Apheresis for collection of peripheral blood mononuclear cells (PBMC) will occur on-site\n* Stem cell collection on-site post-apheresis per standard care.\n* Administration of Cyclophosphamide and fludarabine in pre-determined doses 1 x daily for 3 consecutive days.\n* Hospitalization to receive Cilta-cel in per-determined dose per protocol 1 x daily for 3 consecutive days and will remain in the hospital for 2 weeks post cilta-cell infusion.\n* Follow-up for 3 years post-treatment and up to 15 years.","label":"Cilta-Cel Dose Expansion Cohort","type":"EXPERIMENTAL"}],"collaborators":["Janssen Research & Development, LLC"],"completion_date":{"date":"2040-01-15","type":"ESTIMATED"},"conditions":["Multiple Myeloma","Smoldering Multiple Myeloma"],"enrollment":{"count":20,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Ciltacabtagene Autoleucel","otherNames":["Cilta-cel, JNJ-68284528, LCAR-B38M"],"type":"DRUG"},{"name":"Cyclophosphamide","otherNames":["Cytoxan"],"type":"DRUG"},{"name":"Fludarabine Phosphate","otherNames":["Fludarabine, Fludara"],"type":"DRUG"}],"last_update":"2026-03-12","lead_sponsor":"Dana-Farber Cancer Institute","official_title":"CAR- PRISM (PRecision Intervention Smoldering Myeloma): A Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in High-Risk Smoldering Myeloma","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2025-12-15","type":"ACTUAL"},"primary_outcomes":[{"measure":"Incidence of Dose Limiting Toxicities (DLT)","timeFrame":"24 months"},{"measure":"Nature of Dose Limiting Toxicities (DLT)","timeFrame":"24 months"},{"measure":"Incidence of Adverse Events (AEs)","timeFrame":"24 months"}],"references":[{"citation":"Nadeem O, Cordas Dos Santos DM, Nikiforow S, Bosch-Vilaseca A, O'Donnell E, Redd R, DeBraganca KC, Sperling AS, Liu Y, McEntire C, Arters F, O'Donnell C, Kineavy B, Marto M, Bergeron A, Swenson E, McHugh K, Caron A, Berry Q, Wei H, Durlacher E, Grimm E, Corrado F, Bidikian N, Montes de Oca R, Lengil T, De Wiest D, Gervais C, Panaro K, Smith EL, Anderson K, Jacobson C, Munshi NC, Richardson P, Madduri D, Schecter JM, Tendler C, Wildgust MA, Trippa L, Mateos MV, Ritz J, Ghobrial IM. Ciltacabtagene autoleucel in high-risk smoldering multiple myeloma: the CAR-PRISM phase 2 trial. Nat Med. 2026 Jul;32(7):2420-2429. doi: 10.1038/s41591-026-04365-y. Epub 2026 Apr 20.","pmid":"42010117","type":"DERIVED"}],"start_date":{"date":"2023-04-19","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"CAR- PRISM (PRecision Intervention Smoldering Myeloma)","url":"https://clinicaltrials.gov/study/NCT05767359"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/car-prism-nct05767359"}